FDA inspectors are instructed to review validations at companies that employ sterilization processes.Description
This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.
Ethylene oxide/EO continues to be used to sterilize tremendous volumes of medical products worldwide. Its versatility has been employed for both in-house and contract sterilization for manufacturers, in addition to hospital and university applications. Sterilization is designated as a special validation process by both FDA and ISO, having unique requirements.
FDA inspectors are instructed to review validations at companies that employ sterilization processes. This presentation will review the general requirements for performing EO validations via the "overkill" half-cycle method as described in ISO 11135.You Will Learn:
Who Will Benefit:
- General requirements of ISO 11135
- Items to be included in the validation protocol
- Equipment, materials, monitoring devices used during validation
- Activities performed during the execution of the study
- Items to be included in the final report
- Post-validation issues
Online Version Available
- Validation staff that must cross-train for ISO sterilizer validations
- Laboratory staff involved with validation activities
- Quality or Regulatory staff now being assigned sterilizer audit responsibilities
- Supervisors of Manufacturing or Laboratory Departments responsible for sterilization processes
- Auditors responsible for reviewing contract sterilizer documents
- Anyone needing to gain a basic understanding of the requirements of EO validation process or documentation
If you would like to access this course online, simply purchase the course, and a representative will contact you within 2 business days with your access to recording link along with reference materials.